<p>纽约，2025 年 12 月 11 日（GLOBE NEWSWIRE）——Mesoblast Limited（纳斯达克代码：MESO；澳大利亚证券交易所代码：MSB），全球领先的用于治疗炎症疾病的异体细胞药物公司，今天宣布在佛罗里达州举行的第 67 届 ASH 年会上，展示了一项关于 remestemcel-L 与 ruxolitinib 在治疗类固醇耐药急性移植物抗宿主病（SR-aGvHD）方面的疗效和安全性的独立同行评审比较分析。独立研究作者得出结论，remestemcel-L 在完全缓解和总体缓解方面的结果优于 ruxolitinib。1</p>
<p>这项荟萃分析涉及 2732 名患者（治疗组 1993 名，控制组 523 名），共包括 11 项研究。在治疗组中，644 名患者接受了 remestemcel-L 治疗，1349 名患者接受了 ruxolitinib 治疗。虽然 ruxolitinib 和 remestemcel-L 在治疗 SR-aGvHD 方面均显著改善了生活质量，但 remestemcel-L 在完全缓解和总体缓解方面的结果更为优越，并且在血液学、心脏和肝脏不良事件方面存在差异。作者还得出结论，尽管这两种疗法均表现出良好的安全性，但临床决策应考虑不良事件的差异。</p>
<p>Ryoncil®是美国食品药品监督管理局（FDA）批准的首个间充质基质细胞（MSC）产品，适用于任何适应症，也是唯一一款针对 12 岁以下 SR-aGvHD 儿童的批准产品。2</p>
<p>《Blood》杂志的_Spotlight_栏目，ASH 的旗舰期刊，强调了 FDA 对 Ryoncil®的批准是急性 GvHD 治疗领域的重要进展。3</p>
<p><strong>关于 Mesoblast</strong></p>
<p>Mesoblast（公司）是开发异体（现成）细胞药物以治疗严重和危及生命的炎症疾病的全球领导者。该公司的专有间充质谱系细胞治疗技术平台通过释放抗炎因子来应对严重炎症，抵消和调节免疫系统的多个效应臂，从而显著减少有害的炎症过程。</p>
<p>Mesoblast 的 Ryoncil®（remestemcel-L-rknd）用于治疗 2 个月及以上儿童的类固醇耐药急性移植物抗宿主病（SR-aGvHD），是首个获得 FDA 批准的间充质基质细胞（MSC）疗法。请参阅完整的处方信息，网址为 www.ryoncil.com。</p>
<p>Mesoblast 致力于基于其 remestemcel-L 和 rexlemestrocel-L 异体基质细胞技术平台开发针对不同适应症的额外细胞疗法。Ryoncil®正在开发用于包括成人 SR-aGvHD 和生物抵抗性炎症性肠病在内的其他炎症疾病。Rexlemestrocel-L 正在开发用于心力衰竭和慢性下背痛。该公司在日本、欧洲和中国建立了商业合作伙伴关系。</p>
<p><strong>关于 Mesoblast 的知识产权：</strong> Mesoblast 拥有强大而广泛的全球知识产权组合，涵盖了超过 1000 项已授予的专利或专利申请，涉及间充质基质细胞的组成、制造方法和适应症。这些已授予的专利和专利申请在所有主要市场提供商业保护，延续至至少 2044 年。</p>
<p><strong>关于 Mesoblast 的制造：</strong> 该公司的专有制造工艺可生产工业规模的冷冻保存现成细胞药物。这些细胞疗法具有明确的药品释放标准，计划在全球范围内为患者提供便捷的获取。</p>
<p>Mesoblast 在澳大利亚、美国和新加坡设有办事处，并在澳大利亚证券交易所（MSB）和纳斯达克（MESO）上市。有关更多信息，请访问 www.mesoblast.com，LinkedIn: Mesoblast Limited 和 X: @Mesoblast</p>
<p><strong>参考文献/脚注</strong></p>
<ol>
<li>Ramteke HD 等。ruxolitinib 和 remestemcel-L 在治疗类固醇耐药急性移植物抗宿主病中的比较疗效和安全性：系统评价和荟萃分析。海报。<em>Blood</em> 146 (2025) 6030。https://doi.org/10.1182/blood-2025-6030</li>
<li>请参阅完整的处方信息，网址为 www.ryoncil.com</li>
<li>Etra A, Ferrara JLM, Levine JE。Remestemcel-L-rknd（Ryoncil）：首个获得批准的类固醇耐药急性 GVHD 细胞疗法。_Blood._2025 年 10 月 16 日；146(16)：1897–1901</li>
</ol>
<p><strong>前瞻性声明</strong></p>
<p>本新闻稿包含与未来事件或我们未来财务表现相关的前瞻性声明，并涉及已知和未知的风险、不确定性以及其他可能导致我们实际结果、活动水平、表现或成就与这些前瞻性声明所表达或暗示的任何未来结果、活动水平、表现或成就存在重大差异的因素。我们根据 1995 年《私人证券诉讼改革法案》和其他联邦证券法的安全港条款发布此类前瞻性声明。前瞻性声明不应被视为对未来表现或结果的保证，实际结果可能与这些前瞻性声明中预期的结果不同，而这种差异可能是重大且不利的。前瞻性声明包括但不限于关于：Mesoblast 的临床前和临床研究的启动、时间、进展和结果，以及 Mesoblast 的研究和开发项目；Mesoblast 将产品候选者推进到临床研究的能力，包括多国临床试验的招募和成功完成；Mesoblast 提升其制造能力的能力；监管申请和批准、制造活动和产品营销活动的时间或可能性（如有）；Mesoblast 的 RYONCIL 用于儿童 SR-aGVHD 的商业化及任何其他产品候选者（如获批准）；围绕干细胞治疗的监管或公众认知及市场接受度；Mesoblast 的产品候选者（如有获批准）因患者不良事件或死亡而可能被撤回市场的潜在性；战略合作协议的潜在利益及 Mesoblast 进入和维持既定战略合作的能力；Mesoblast 在其产品候选者上的知识产权的建立和维护能力，以及在涉嫌侵权的情况下成功捍卫这些权利的能力；Mesoblast 能够为其产品候选者和技术建立和维持的知识产权保护范围；Mesoblast 的费用、未来收入、资本需求及其对额外融资的需求的估计；Mesoblast 的财务表现；与 Mesoblast 的竞争对手和行业相关的发展；以及 Mesoblast 的产品候选者（如获批准）的定价和报销。您应将本新闻稿与我们最近提交给 SEC 的报告或我们网站上的风险因素一起阅读。可能导致 Mesoblast 的实际结果、表现或成就与这些声明所表达或暗示的存在重大差异的不确定性和风险，因此，您不应对这些前瞻性声明过度依赖。我们不承担任何公开更新或修订任何前瞻性声明的义务，无论是由于新信息、未来发展还是其他原因。</p>
<p>发布经首席执行官授权。</p>
<p><em>如需更多信息，请联系：</em></p>
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<td></td>
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<td>T: +61 3 9639 6036</td>
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<td><strong><em>媒体 – 全球</em></strong></td>
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<td><strong><em>媒体 – 澳大利亚</em></strong></td>
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<p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZd01URTBNeU0zTXpFNE56UTJJekl3TVRjME16ST0?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZd01URTBNeU0zTXpFNE56UTJJekl3TVRjME16ST0"/></p>
<p><img src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/NjliM2NiZWMtM2ZhYy00MTMyLTlhYTctNDZkODY2YmI3ZjgyLTEwMjkwMDUtMjAyNS0xMi0xMS1lbg==/tiny/Mesoblast-Limited.png?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://ml.globenewswire.com/media/NjliM2NiZWMtM2ZhYy00MTMyLTlhYTctNDZkODY2YmI3ZjgyLTEwMjkwMDUtMjAyNS0xMi0xMS1lbg==/tiny/Mesoblast-Limited.png"/></p>

MESO

<p>在 ASH 年会上发布的一项独立研究得出结论，Mesoblast 的 remestemcel-L 在治疗类固醇耐药性急性移植物抗宿主病（SR-aGvHD）方面优于 ruxolitinib。该研究涉及 2732 名患者，显示 remestemcel-L 在完全缓解和总体缓解方面的结果更佳。两种治疗方法均改善了生活质量，但 remestemcel-L 的不良事件较少。Mesoblast 的 Ryoncil®是 FDA 批准的首个用于 12 岁以下儿童 SR-aGvHD 的间充质基质细胞治疗</p>

<p>NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that an independent peer-reviewed comparative analysis of efficacy and safety between remestemcel-L and ruxolitinib for treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) was presented at the 67th ASH Annual meeting in Florida this past week. The independent study authors concluded that remestemcel-L showed superior outcomes in complete and overall remission compared with ruxolitinib.1</p>
<div class="lb-trans"><p>纽约，2025 年 12 月 11 日（GLOBE NEWSWIRE）——Mesoblast Limited（纳斯达克代码：MESO；澳大利亚证券交易所代码：MSB），全球领先的用于治疗炎症疾病的异体细胞药物公司，今天宣布在佛罗里达州举行的第 67 届 ASH 年会上，展示了一项关于 remestemcel-L 与 ruxolitinib 在治疗类固醇耐药急性移植物抗宿主病（SR-aGvHD）方面的疗效和安全性的独立同行评审比较分析。独立研究作者得出结论，remestemcel-L 在完全缓解和总体缓解方面的结果优于 ruxolitinib。1</p>
</div><p>The meta-analysis involved 2,732 patients (1,993 in the treatment arms and 523 in the control arms) across 11 studies. Among treatment groups, 644 patients received remestemcel-L and 1,349 received ruxolitinib. While both ruxolitinib and remestemcel-L significantly improved quality of life in treating SR-aGvHD, remestemcel-L showed superior outcomes in complete and overall remission as well as differences in hematology, cardiac and hepatic adverse events. The authors also concluded that while both therapies exhibit favorable safety profiles, clinical decisions should consider the differences in adverse events.</p>
<div class="lb-trans"><p>这项荟萃分析涉及 2732 名患者（治疗组 1993 名，控制组 523 名），共包括 11 项研究。在治疗组中，644 名患者接受了 remestemcel-L 治疗，1349 名患者接受了 ruxolitinib 治疗。虽然 ruxolitinib 和 remestemcel-L 在治疗 SR-aGvHD 方面均显著改善了生活质量，但 remestemcel-L 在完全缓解和总体缓解方面的结果更为优越，并且在血液学、心脏和肝脏不良事件方面存在差异。作者还得出结论，尽管这两种疗法均表现出良好的安全性，但临床决策应考虑不良事件的差异。</p>
</div><p>Ryoncil® is the first mesenchymal stromal cell (MSC) product approved by the U.S. Food and Drug Administration (FDA) for any indication, and the only product approved for children under age 12 with SR-aGvHD.2</p>
<div class="lb-trans"><p>Ryoncil®是美国食品药品监督管理局（FDA）批准的首个间充质基质细胞（MSC）产品，适用于任何适应症，也是唯一一款针对 12 岁以下 SR-aGvHD 儿童的批准产品。2</p>
</div><p>The <em>Spotlight</em> segment of <em>Blood</em>, the flagship journal of ASH, featured FDA approval of Ryoncil® as an important advance in the field for treatment of acute GvHD.3</p>
<div class="lb-trans"><p>《Blood》杂志的_Spotlight_栏目，ASH 的旗舰期刊，强调了 FDA 对 Ryoncil®的批准是急性 GvHD 治疗领域的重要进展。3</p>
</div><p><strong>About Mesoblast</strong></p>
<div class="lb-trans"><p><strong>关于 Mesoblast</strong></p>
</div><p>Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.</p>
<div class="lb-trans"><p>Mesoblast（公司）是开发异体（现成）细胞药物以治疗严重和危及生命的炎症疾病的全球领导者。该公司的专有间充质谱系细胞治疗技术平台通过释放抗炎因子来应对严重炎症，抵消和调节免疫系统的多个效应臂，从而显著减少有害的炎症过程。</p>
</div><p>Mesoblast’s Ryoncil® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.</p>
<div class="lb-trans"><p>Mesoblast 的 Ryoncil®（remestemcel-L-rknd）用于治疗 2 个月及以上儿童的类固醇耐药急性移植物抗宿主病（SR-aGvHD），是首个获得 FDA 批准的间充质基质细胞（MSC）疗法。请参阅完整的处方信息，网址为 www.ryoncil.com。</p>
</div><p>Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.</p>
<div class="lb-trans"><p>Mesoblast 致力于基于其 remestemcel-L 和 rexlemestrocel-L 异体基质细胞技术平台开发针对不同适应症的额外细胞疗法。Ryoncil®正在开发用于包括成人 SR-aGvHD 和生物抵抗性炎症性肠病在内的其他炎症疾病。Rexlemestrocel-L 正在开发用于心力衰竭和慢性下背痛。该公司在日本、欧洲和中国建立了商业合作伙伴关系。</p>
</div><p><strong>About Mesoblast intellectual property:</strong> Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.</p>
<div class="lb-trans"><p><strong>关于 Mesoblast 的知识产权：</strong> Mesoblast 拥有强大而广泛的全球知识产权组合，涵盖了超过 1000 项已授予的专利或专利申请，涉及间充质基质细胞的组成、制造方法和适应症。这些已授予的专利和专利申请在所有主要市场提供商业保护，延续至至少 2044 年。</p>
</div><p><strong>About Mesoblast manufacturing:</strong> The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.</p>
<div class="lb-trans"><p><strong>关于 Mesoblast 的制造：</strong> 该公司的专有制造工艺可生产工业规模的冷冻保存现成细胞药物。这些细胞疗法具有明确的药品释放标准，计划在全球范围内为患者提供便捷的获取。</p>
</div><p>Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and X: @Mesoblast</p>
<div class="lb-trans"><p>Mesoblast 在澳大利亚、美国和新加坡设有办事处，并在澳大利亚证券交易所（MSB）和纳斯达克（MESO）上市。有关更多信息，请访问 www.mesoblast.com，LinkedIn: Mesoblast Limited 和 X: @Mesoblast</p>
</div><p><strong>References / Footnotes</strong></p>
<div class="lb-trans"><p><strong>参考文献/脚注</strong></p>
</div><ol>
<li>Ramteke HD, et al. Comparative efficacy and safety of ruxolitinib and remestemcel-L in the treatment of steroid-refractory acute graft-versus-host disease: Systematic review and meta-analysis. Poster. <em>Blood</em> 146 (2025) 6030. https://doi.org/10.1182/blood-2025-6030</li>
<li>Please see the full Prescribing Information at www.ryoncil.com</li>
<li>Etra A, Ferrara JLM, Levine JE. Remestemcel-L-rknd (Ryoncil): the first approved cellular therapy for steroid-refractory acute GVHD. <em>Blood.</em> 2025 October 16; 146(16): 1897–1901</li>
</ol>
<div class="lb-trans"><ol>
<li>Ramteke HD 等。ruxolitinib 和 remestemcel-L 在治疗类固醇耐药急性移植物抗宿主病中的比较疗效和安全性：系统评价和荟萃分析。海报。<em>Blood</em> 146 (2025) 6030。https://doi.org/10.1182/blood-2025-6030</li>
<li>请参阅完整的处方信息，网址为 www.ryoncil.com</li>
<li>Etra A, Ferrara JLM, Levine JE。Remestemcel-L-rknd（Ryoncil）：首个获得批准的类固醇耐药急性 GVHD 细胞疗法。_Blood._2025 年 10 月 16 日；146(16)：1897–1901</li>
</ol>
</div><p><strong>Forward-Looking Statements</strong></p>
<div class="lb-trans"><p><strong>前瞻性声明</strong></p>
</div><p>This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.</p>
<div class="lb-trans"><p>本新闻稿包含与未来事件或我们未来财务表现相关的前瞻性声明，并涉及已知和未知的风险、不确定性以及其他可能导致我们实际结果、活动水平、表现或成就与这些前瞻性声明所表达或暗示的任何未来结果、活动水平、表现或成就存在重大差异的因素。我们根据 1995 年《私人证券诉讼改革法案》和其他联邦证券法的安全港条款发布此类前瞻性声明。前瞻性声明不应被视为对未来表现或结果的保证，实际结果可能与这些前瞻性声明中预期的结果不同，而这种差异可能是重大且不利的。前瞻性声明包括但不限于关于：Mesoblast 的临床前和临床研究的启动、时间、进展和结果，以及 Mesoblast 的研究和开发项目；Mesoblast 将产品候选者推进到临床研究的能力，包括多国临床试验的招募和成功完成；Mesoblast 提升其制造能力的能力；监管申请和批准、制造活动和产品营销活动的时间或可能性（如有）；Mesoblast 的 RYONCIL 用于儿童 SR-aGVHD 的商业化及任何其他产品候选者（如获批准）；围绕干细胞治疗的监管或公众认知及市场接受度；Mesoblast 的产品候选者（如有获批准）因患者不良事件或死亡而可能被撤回市场的潜在性；战略合作协议的潜在利益及 Mesoblast 进入和维持既定战略合作的能力；Mesoblast 在其产品候选者上的知识产权的建立和维护能力，以及在涉嫌侵权的情况下成功捍卫这些权利的能力；Mesoblast 能够为其产品候选者和技术建立和维持的知识产权保护范围；Mesoblast 的费用、未来收入、资本需求及其对额外融资的需求的估计；Mesoblast 的财务表现；与 Mesoblast 的竞争对手和行业相关的发展；以及 Mesoblast 的产品候选者（如获批准）的定价和报销。您应将本新闻稿与我们最近提交给 SEC 的报告或我们网站上的风险因素一起阅读。可能导致 Mesoblast 的实际结果、表现或成就与这些声明所表达或暗示的存在重大差异的不确定性和风险，因此，您不应对这些前瞻性声明过度依赖。我们不承担任何公开更新或修订任何前瞻性声明的义务，无论是由于新信息、未来发展还是其他原因。</p>
</div><p>Release authorized by the Chief Executive.</p>
<div class="lb-trans"><p>发布经首席执行官授权。</p>
</div><p><em>For more information, please contact:</em></p>
<div class="lb-trans"><p><em>如需更多信息，请联系：</em></p>
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</div><p><img src="https://imageproxy.pbkrs.com/https://www.globenewswire.com/newsroom/ti/query-bmY9T1RZd01URTBNeU0zTXpFNE56UTJJekl3TVRjME16ST0" alt="" original-src="https://www.globenewswire.com/newsroom/ti?nf=OTYwMTE0MyM3MzE4NzQ2IzIwMTc0MzI="/></p>
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Independent Study Presented at American Society of Hematology (ASH) Annual Meeting Concludes Remestemcel-L Superior to Ruxolitinib in Clinical Outcomes as Treatment for SR-aGvHD | MESO Stock News

在美国血液学会（ASH）年会上展示的一项独立研究得出结论，Remestemcel-L 在临床效果上优于 Ruxolitinib，作为治疗 SR-aGvHD 的方法 | MESO 股票新闻